Onsite Pharmaceutical Quality Engineer & Validation SME

The FDA Group; Philadelphia (Philadelphia County); On-site; USD 96,000 - 152,000; Full time

Job summary

The FDA Group is seeking an experienced Pharmaceutical Quality Engineer Consultant to provide temporary onsite quality coverage in Southern New Jersey for 6–7 months. The role focuses on sterile operations, aseptic processing, water systems, and validation activities, with emphasis on cGMP compliance.

You will support technology transfer, change control, risk assessments, CAPA, and ongoing quality initiatives while ensuring manufacturing processes meet regulatory requirements.

Qualifications

• Minimum of 5 years of Quality experience in a regulated pharmaceutical drug manufacturing environment.
• Strong working knowledge of FDA pharmaceutical manufacturing requirements, including 21 CFR Parts 210 and 211.
• Experience supporting commissioning, qualification, process validation, and/or cleaning validation activities.
• Demonstrated ability to lead or support investigations, root‑cause analysis, CAPA, risk assessments, and change controls.
• Ability to work onsite in Southern New Jersey for the duration of the engagement.

Responsibilities

• Coordinate Quality activities associated with technology and design transfer for inter-site production and external manufacturing.
• Evaluate new and existing processes against regulatory, customer, and cGMP requirements.
• Influence process design through process controls, risk-based decision-making, and proactive identification of potential Quality risks.
• Develop validation strategies in accordance with applicable regulatory and customer requirements.
• Support commissioning, equipment qualification, process validation, and cleaning validation activities.
• Collaborate with process engineers to author, review, and approve specifications, qualification protocols and reports, validation protocols and reports, and production documentation.
• Oversee and coordinate execution of qualification and validation protocols as required.
• Develop Quality plans for components and products using appropriate statistical techniques and approved inspection methods.
• Identify and implement process improvements that enhance product quality, reduce variation, and improve operational efficiency.
• Evaluate engineering change controls affecting specifications, qualified equipment, validated processes, and related systems.
• Serve as the Quality lead for root‑cause investigations and implementation of corrective and preventive actions.

Skills

Quality experience

FDA cGMP knowledge

CAPA & investigations

Onsite availability

Process validation

Tools

MasterControl

Job description

The FDA Group is seeking an experienced Pharmaceutical Quality Engineer Consultant to provide temporary onsite quality coverage in Southern New Jersey for 6–7 months. The role focuses on sterile operations, aseptic processing, water systems, and validation activities, with emphasis on cGMP compliance.

You will support technology transfer, change control, risk assessments, CAPA, and ongoing quality initiatives while ensuring manufacturing processes meet regulatory requirements.